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Evaluation of the Effect of Different Biomaterials on Palatal Wound Healing.

Evaluation of the Effect of Different Biomaterials on Palatal Wound Healing. A Randomized Controlled Clinical Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07072182
Enrollment
40
Registered
2025-07-18
Start date
2025-03-20
Completion date
2025-06-20
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heal Wound, VAS Will be Used to Assess Pain Postoperative

Brief summary

All study subjects will sign written informal consent form before enrolment. They will be divided into four groups, 10 patients each: * Group I: Palatal wound will be left to heal spontaneously, * Group II: Palatal wound will be covered with Composite stent, * Group III: Palatal wound will be covered with PRF, * Group IV: Palatal wound will be covered with Ora-aid patch. III- Surgical Procedures: - * After harvesting the palatal soft tissue graft with the standardized dimensions (12 × 7 mm) of the graft for all patients. Graft thickness was standardized as well to be approximately 1.5 to 2 mm and confirmed with a caliper at 3 points (ends and centre of the graft). Fixing of the graft at the recipient site will be performed, back to the donor site for management, the blood clot will be wiped with gauze, then placement of different materials according to each group. * The dressing will be then pressed gently for 10 seconds, to aid its adherence to the wound. Fixation of the patch will be followed, using 5/0 propylene suture, with performing sling horizontal figure eight suture technique.

Interventions

DEVICEPalatal wound will be covered with Ora-aid patch

Palatal wound will be covered with Ora-aid patch

DEVICEPalatal wound will be covered with Composite stent

Palatal wound will be covered with Composite stent

COMBINATION_PRODUCTPalatal wound will be covered with PRF

Palatal wound will be covered with PRF

Sponsors

Fatma saad saad mahmoud elsherbini
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

- * Patients who are indicated for soft tissue augmentation procedures, either with root coverage or to increase the deficient keratinized tissue, * Medically free patients, * Non-smokers and * Patients with good oral hygiene.

Exclusion criteria

- * Pregnant or lactating females, * Patients with untreated periodontal condition and * Patients with uncontrolled systemic condition.

Design outcomes

Primary

MeasureTime frameDescription
Wound healing assessmentFrom enrollment to the end of treatment at 4 weeksThe parameters of tissue color, bleeding response to palpation, presence of granulation tissue, characteristics of the incision margins, and the presence of suppuration were evaluated as this index assesses wound healing using scores from 1 to 5: a wound with very poor healing receives a score of 1, whereas excellent healing gets a score of 5.
Pain using the visual analogue scaleFrom enrollment to the end of treatment at 4 weeksPatients were asked about their pain levels, swelling, and other experiences related to the surgical techniques and instruments to assess postoperative pain. The perceived discomfort was rated using a VAS, which is marked at two endpoints: no discomfort at one end (score of 0) and unbearable discomfort at the other end (score of 10). Patients completed the questionnaires on the 1st, 2nd, 4th, 7th, and 14th days after their surgery

Secondary

MeasureTime frameDescription
Patient satisfaction through direct communicationFrom enrollment to the end of treatment at 4 weeksPatient satisfaction (PS) was evaluated using a three-point rating scale: 3 for fully satisfied, 2 for satisfied, and 1 for unsatisfied. Each patient was asked about their satisfaction with the following patient-centered criteria: root coverage achieved, relief from dentinal hypersensitivity, color of the gingiva, shape and contour of the gingiva, surgical procedure (including pain during surgery and discomfort related to the duration of the procedure and the operator's handling), post-surgical phase (including pain, swelling, and any postoperative complications), and cost-effectiveness (patients were asked if they felt the treatment justified the time and money spent). This approach aimed to gather comprehensive feedback on the overall patient experience

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026